Actively Recruiting
Low-Dose Radiotherapy Combined With Anti-PD-1 Immunotherapy as Neoadjuvant Treatment for Surgically Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma
Led by Xiwei XU · Updated on 2026-02-03
22
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new treatment for patients with locally advanced head and neck squamous cell carcinoma (HNSCC), a condition where more than 60% of patients are diagnosed at an advanced stage. Despite current standard treatments such as surgery and chemoradiotherapy, many patients experience local recurrence within two years. This trial aims to evaluate a neoadjuvant approach combining low-dose radiotherapy with an anti-PD-1 immunotherapy to improve long-term survival based on encouraging evidence that low-dose radiotherapy can enhance immune response alongside immunotherapy. Participants will receive two cycles of neoadjuvant treatment consisting of low-dose radiotherapy (1 Gy per fraction on Days 1, 8, and 15) combined with the anti-PD-1 monoclonal antibody Toripalimab (240 mg on Day 1 every 3 weeks). Surgical resection follows 3-4 weeks after neoadjuvant therapy. After surgery, patients receive adjuvant treatments including radiotherapy (dose depending on risk group) and possibly cisplatin chemotherapy for high-risk patients. The study is a single-arm Phase II clinical trial led by Xiwei XU. During the study, participants will be closely monitored through pathological assessments one week post-surgery to measure treatment response and tumor remission. Researchers will track progression-free survival, overall survival, quality of life, and adverse events over one to two years. The total duration includes neoadjuvant therapy, surgery, adjuvant treatments, and long-term follow-up to evaluate safety and effectiveness of the combined regimen.
CONDITIONS
Brief Title
Low-Dose Radiotherapy and Anti-PD-1 Immunotherapy as Neoadjuvant Treatment for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign and date the informed consent form.
- Untreated, histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx, or larynx) with CPS 1.
- Cancer classified as stage T3-4bN0M0 or T1-4bN1-3M0, corresponding to stage III-IVB.
- Eligible for curative surgery based on surgeon's assessment.
- Age between 18 and 75 years.
- ECOG performance status of 0 or 1.
- Life expectancy greater than 6 months.
- At least one measurable lesion per RECIST 1.1 criteria.
- Adequate organ function as defined by specific blood and biochemical parameters.
- Women of childbearing potential must use effective contraception during treatment and for 3 months after.
- Good compliance with the study protocol.
You will not qualify if you...
- Pregnant or lactating women.
- History of allergy to PD-1 inhibitors.
- History of other malignancies within the past 5 years except certain cured cancers.
- Uncontrolled cardiac symptoms or diseases such as heart failure NYHA Class II or higher, unstable angina, recent myocardial infarction, or significant arrhythmias.
- Prior investigational drug use before study drug.
- Concurrent participation in another clinical study except specified exceptions.
- Systemic corticosteroid or immunosuppressive treatment within 2 weeks prior to study drug, with some exceptions.
- Live vaccine administration within 4 weeks prior to study drug.
- Major surgery or severe trauma within 4 weeks prior to study drug.
- Severe infection or active pulmonary inflammation within specified timeframes.
- History of active autoimmune diseases except some resolved conditions.
- History of immunodeficiency including HIV or organ/bone marrow transplantation.
- Active or recent tuberculosis infection.
- Active hepatitis B or C infection.
- Known substance or alcohol abuse.
- Considered ineligible by investigator judgment.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks (2 cycles, 3 weeks each)
Participants receive low-dose radiotherapy combined with anti-PD-1 immunotherapy prior to surgery.
Radiotherapy on Days 1, 8, and 15 of each cycle; Immunotherapy on Day 1 of each cycle
Duration - 1 day
Participants undergo radical surgery 3-4 weeks after completion of neoadjuvant therapy, following re-evaluation by the surgeon.
1 surgical procedure visit
Duration - Approximately 45 weeks (15 cycles, 3 weeks each)
Participants receive adjuvant immunotherapy with Toripalimab and may receive adjuvant radiotherapy with or without cisplatin chemotherapy depending on risk assessment.
Immunotherapy on Day 1 of each 3-week cycle; Radiotherapy daily over several weeks; Cisplatin chemotherapy on Day 1 of every 3-week cycle for 3 cycles if high-risk
Duration - Up to 2 years after enrollment
Participants are monitored for safety, disease progression, and quality of life after treatment completion.
Regular visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
The Fifth Affiliated Hospital,Sun Yat-sen University
Guangdong, China
Actively Recruiting
Research Team
X
Xiaoting Cai, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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